US20080183128A1 - Methods, devices and systems for treatment and/or diagnosis of disorders of the ear, nose and throat - Google Patents

Abstract

A method for irrigating a paranasal sinus may involve advancing a distal portion of a sinus irrigation catheter through an ostium of a paranasal sinus into the sinus and passing fluid through multiple ports disposed at different locations along a length of the catheter distal portion into the sinus. A flexible irrigation catheter device for irrigating a paranasal sinus may include: an elongate catheter body having a proximal end, a distal end, a lumen therebetween, and a tapered distal portion extending proximally from the distal end of the catheter body; a proximal hub coupled with the proximal end of the catheter body for connecting to a source of irrigation fluid; multiple side ports disposed along the catheter body closer to the distal end than the proximal end and in fluid communication with the lumen; and a distal end port at the distal end of the catheter body.

Description

• This claims priority to U.S. Provisional Patent Application Ser. No. 60/897,446 (Attorney Docket No. ACCL-007CIPPRV), entitled “Methods, Devices and Systems for Treatment and/or Diagnosis of Disorders of the Ear, Nose and Throat,” filed Jan. 24, 2007, the full disclosure of which is hereby incorporated by reference.
• This application hereby incorporates each of the following documents herein, in their entireties, by reference thereto: U.S. application Ser. No. 11/193,020, filed Jul. 29, 2005; U.S. application Ser. No. 10/829,917 filed on Apr. 21, 2004; U.S. Patent Application Publication No. 2005/0240147; U.S. application Ser. No. 10/944,270 filed on Sep. 17, 2004; U.S. Patent Application Publication No. 2006/0004323; U.S. application Ser. No. 11/116,118 filed on Apr. 26, 2005; U.S. Patent Application Publication No. 2006/0004286; U.S. application Ser. No. 11/150,847 filed on Jun. 10, 2005; U.S. Patent Application Publication No. 2006/0210605; U.S. application Ser. No. 11/037,548 filed on Jan. 18, 2005; U.S. application Ser. No. 10/912,578 filed on Aug. 4, 2004; U.S. Patent Application Publication No. 2005/0245906; U.S. application Ser. No. 11/522,497, filed Sep. 15, 2006; and U.S. Provisional Application No. 60/844,874, filed Sep. 15, 2006.
BACKGROUND OF THE INVENTION
• Surgical treatments for sinusitis and other disorders of the ear, nose and throat have evolved slowly over the years. In current clinical practice, functional endoscopic sinus surgery (FESS) is often used to treat sinusitis or other disorders where drainage of mucous is impaired and/or chronic infections are present. In FESS, an endoscope is inserted into the nose and, under visualization through the endoscope, the surgeon may remove diseased or hypertrophic tissue or bone and may enlarge the ostia of the sinuses to restore normal drainage of the sinuses. FESS procedures can be effective in the treatment of sinusitis and for the removal of tumors, polyps and other aberrant growths from the nose. Other endoscopic intranasal procedures have been used to remove pituitary tumors, to treat Graves disease (i.e., a complication of hyperthyroidism which results in protrusion of the eyes) and surgical repair of rare conditions wherein cerebrospinal fluid leaks into the nose (i.e., cerebrospinal fluid rhinorrhea).
• The surgical instruments used in the prior art FESS procedures having included applicators, chisels, curettes, elevators, forceps, gouges, hooks, knives, saws, mallets, morselizers, needle holders, osteotomes, ostium seekers, probes, punches, backbiters, rasps, retractors, rongeurs, scissors, snares, specula, suction cannulae and trocars. The majority of such instruments are of substantially rigid design.
• Although FESS continues to be the gold standard therapy for severe sinuses, it has several shortfalls. Often patients complain of the post-operative pain and bleeding associated with the procedure, and a significant subset of patients remain symptomatic even after multiple surgeries. Since FESS is considered an option only for the most severe cases (those showing abnormalities under CT scan), a large population of patients exist that can neither tolerate the prescribed medications nor be considered candidates for surgery. Further, because the methodologies to assess sinus disease are primarily static measurements (CT, MRI), patients whose symptoms are episodic are often simply offered drug therapy when in fact underlying mechanical factors may play a significant role. This leaves a large population of patients in need of relief, unwilling or afraid to take steroids, but not sick enough to qualify for FESS surgery.
• Some experimental or investigational procedures have also been performed in an effort to treat sinusitis by methods that are less invasive and/or less damaging to ancillary tissues than FESS: For example, European physicians have reported the use of a hydrophilic guidewire and standard PTCA balloon catheter to treat restenosis of surgically created openings in diseased frontal sinuses and stenotic nasal conae. Gottmann, D., Strohm, M., Strecker, E. P., Karlsruhe, D. E., Balloon dilatation of Recurrent Ostial Oclusion of the Frontal Sinus, Abstract No. B-0453, European Congress of Radiology (2001); Strohm, M., Gottmann, D., Treatment of Stenoses of Upper Air Routes by Balloon Dilation, Proceeding of the 83.sup.rd Annual Convention of the Association of West German ENT Physicians (1999). The interventions described in this abstract were conducted only on frontal sinuses that had previously been surgically modified and nasal conae. These techniques were not reported to be useable for the treatment of sinus ostia that has not previously been surgically altered or ostia of sinuses other than the easily accessible frontal sinuses. Also, in these reported cases, standard vascular guidewires and angioplasty balloon catheters were used. The techniques described in these publications have not been widely adopted by ENT surgeons, possibly due to the fact that they lacked important novel improvements and modifications as described in this patent application and prior U.S. patent application Ser. Nos. 10/829,917; 10/912,578; 10/829,917; 10/944,270; 11/116,118; 11/150,847; 11/193,020 and 11/037,548, of which this application is a continuation-in-part.
• Other methods and devices for sinus intervention using dilating balloons have been disclosed in U.S. Pat. No. 2,525,183 (Robison) and U.S. Patent Publication No. 2004/0064150 A1 (Becker). For example, U.S. Pat. No. 2,525,183 (Robison) discloses an inflatable pressure device which can be inserted following sinus surgery and inflated within the sinus. The patent does not disclose device designs and methods for flexibly navigating through the complex nasal anatomy to access the natural ostia of the sinuses. The discussion of balloon materials is also fairly limited to thin flexible materials like rubber which are most likely to be inadequate for dilating the bony ostia of the sinus.
• U.S. patent publication No. 2004/0064150 A1 (Becker) discloses balloon catheters formed of a stiff hypotube to be pushed into a sinus. The balloon catheters have a stiff hypotube with a fixed pre-set angle that enables them to be pushed into the sinus. In at least some procedures wherein it is desired to position the balloon catheter in the ostium of a paranasal sinus, it is necessary to advance the balloon catheter through complicated or tortuous anatomy in order to properly position the balloon catheter within the desired sinus ostium. Also, there is a degree of individual variation in the intranasal and paranasal anatomy of human beings, thus making it difficult to design a stiff-shaft balloon catheter that is optimally shaped for use in all individuals. Indeed, rigid catheters formed of hypotubes that have pre-set angles cannot be easily adjusted by the physician to different shapes to account for individual variations in the anatomy. In view of this, the Becker patent application describes the necessity of having available a set of balloon catheters, each having a particular fixed angle so that the physician can select the appropriate catheter for the patient's anatomy. The requirement to test multiple disposable catheters for fit is likely to be very expensive and impractical. Moreover, if such catheter are disposable items (e.g., not sterilizable and reusable) the need to test and discard a number of catheters before finding one that has the ideal bend angle even further exacerbates the expense factor of Becker's approach.
• More recently, new devices, systems and methods have been devised to enable the performance of FESS procedures and other ENT surgeries with minimal or no removal or modification of normal anatomical structures. Such new methods include, but are not limited to, uncinate-sparing procedures using Balloon Sinuplasty™ tools and uncinate-sparing ethmoidectomy procedures using catheters, non-rigid instruments and advanced imaging techniques (Acclarent, Inc., Menlo Park, Calif.). Examples of these new devices, systems and methods are described in incorporated U.S. patent application Ser. No. 10/829,917 entitled Devices, Systems and Methods for Diagnosing and Treating Sinusitis and Other Disorders of the Ears, Nose and/or Throat; Ser. No. 10/944,270 entitled Apparatus and Methods for Dilating and Modifying Ostia of Paranasal Sinuses and Other Intranasal or Paranasal Structures; Ser. No. 11/116,118 entitled Methods and Devices for Performing Procedures Within the Ear, Nose, Throat and Paranasal Sinuses filed Apr. 26, 2005 and Ser. No. 11/150,847 filed Jun. 10, 2005, each of which is hereby incorporated herein, in its entirety. Procedures using Balloon Sinuplasty™ tools such as those described in the above-noted applications, for example, are performable using various types of guidance including but not limited to C-arm fluoroscopy, transnasal endoscopy, optical image guidance and/or electromagnetic image guidance.
• Lavage or irrigation procedures have been performed with a straight, flexible tube that is advanceable to some regions of the anatomy to deliver irrigatino or suction to the region from an opening in a distal end of the tube. Problems with these tube and procedures have included kinking of the tube when passed through a guide catether having a bend in the distal end portion adapted to bend the tube toward a particular anatomical location, poor tracking over a guidewire to deliver a distal end of the tube to a desired location, possibly due to stiffness (insufficient flexibility) of the tube and/or tolerance between the lumen of the tube and the guidewire over which it is tracking being too great, tube diameter too large for placement in some locations, and tube diameter too large to be used with small guide catheters (having a relatively small inside diameter). Further the ability to completely rinse out an area such as a sinus has sometimes been compromised, by any of the drawbacks mentioned above and/or ineffective spray delivered from the tube.
• There is a continuing need for devices, systems and methods that are optimal for minimally invasive treatment of sinusitis and other ear, nose and throat disorders.
BRIEF DESCRIPTION OF THE DRAWINGS
• FIG. 1 shows components that are useable together in an irrigation system according to one embodiment of the present application.
• FIG. 2A is a partial view of an irrigation catheter according to an embodiment of the present invention.
• FIG. 2B is a longitudinal sectional view ofFIG. 2A.
• FIG. 2C is an enlarged view of the portion ofFIG. 2A withincircle2C.
• FIG. 2D is an enlarged view of the portion ofFIG. 2B withincircle2D.
• FIG. 3A is a partial view of an irrigation system showing a distal tip portion of a stylet extending distally from a distal end of an irrigation catheter.
• FIG. 3B illustrates an irrigation system having been inserted though a guide catheter.
• FIG. 3C is a cross-sectional view of a distal tip portion of a stylet.
• FIG. 3D is a cross-sectional view of an intermediate portion of a stylet.
• FIG. 3E is a cross-sectional view of a proximal portion of a stylet.
• FIG. 3F illustrates a distal tip portion of a stylet having been shaped to set a bend to facilitate steering.
• FIG. 3G is a longitudinal sectional view of a distal tip portion of a stylet and a distal end portion of an irrigation catheter.
• FIG. 4A is a partial, longitudinal sectional view of a removable stylet.
• FIG. 4B is an enlarged view of the portion ofFIG. 4A withincircle4B.
• FIG. 4C is an enlarged view of the portion ofFIG. 4A withincircle4C.
• FIG. 5A is a partial view of an irrigation system comprising an irrigation catheter having an integrated distal tip portion of a stylet.
• FIGS. 5B and 5C are opposite side view of another irrigation system comprising an irrigation catheter having an integrated distal tip portion of a stylet.
• FIG. 6A illustrates a portion of a structurally reinforced tubing.
• FIG. 6B illustrates a portion of an irrigation system having an irrigation catheter with structurally reinforced tubing.
• FIGS. 6C and 6D show a structural reinforcement for a tubing, wherein the structural reinforcement includes reinforcement of a portion of the tubing that includes side openings.
• FIG. 7A illustrates a clippable stylet distal tip portion.
• FIG. 7B illustrates a portion of an irrigation catheter having an integrated stylet distal tip portion.
• FIG. 7C is a cross-sectional view taken alongline7C-7C inFIG. 7B.
• FIG. 7D illustrates a longitudinal sectional view of another clippable stylet distal end portion.
• FIG. 7E illustrates longitudinal sectional views of a kit of clippable stylet distal end portions.
• FIG. 7F illustrates an interchangeable, fixed stylet distal end portion.
• FIGS. 8A-8E show various different radiopaque marker arrangements in irrigation systems.
• FIG. 8F is a partial, longitudinal sectional illustration of an irrigation system including an irrigation catheter and removable stylet.
• FIG. 9A illustrates an irrigation system including an irrigation catheter and removable stylet.
• FIG. 9B illustrates an irrigation system including an irrigation catheter and removable stylet, along with a spacer inserted between hubs of the irrigation catheter and removable stylet.
• FIG. 9C is a side view of a spacer.
• FIG. 9D is an end view of the spacer ofFIG. 9C.
• FIG. 9E is a view of a telescoping spacer.
• FIG. 9F illustrates a locking arrangement for a telescoping spacer.
• FIG. 9G illustrates another adjustable length spacer.
• FIG. 9H illustrates a variation of the spacer shown inFIG. 9G.
• FIG. 9I illustrates an adjustment mechanism integrated into the hub of the removable stylet.
• FIG. 9J illustrates an adjustment mechanism integrated into the hub of the irrigation catheter.
• FIG. 10A illustrates a flexibility property of a stylet distal tip portion.
• FIG. 10B illustrates a shapeability property of a stylet distal tip portion.
• FIGS. 10C-10D illustrate a supportive property of a stylet distal tip portion.
• FIG. 11A is a partial, longitudinal sectional view of an irrigation system including a removable stylet and an irrigation catheter.
• FIG. 11B is a cross-sectional view taken atline11B-11B inFIG. 11A.
• FIG. 11C is a cross-sectional view taken atline11C-11C inFIG. 11A.
• FIG. 11D is a cross-sectional view taken atline11D-11D inFIG. 11A.
• FIG. 12 illustrates an arrangement for delivering high pressure irrigation to an anatomical site within a patient.
• FIGS. 13A-13C illustrate partial view of additional arrangements of irrigation systems in which an irrigation catheter has an integrated stylet distal tip portion.
• FIG. 13D illustrates an embodiment where distal tip portion includes a solid polymer tip that contains a radiopaque coil at a distal portion of the distal tip portion.
• FIG. 14 illustrates a removable illuminating stylet that includes an illuminating distal tip at a distal end of the distal tip portion.
• FIGS. 15A-15D are illustrations of partial sagittal sectional views through a human head showing various steps of a method of gaining access to a paranasal sinus by an irrigation system as described herein to perform at least one of irrigation, suction, delivery of a therapeutic or diagnostic substance or retrieval of a culture.
• FIGS. 16A-16E are illustrations of various views of a flexible irrigation catheter according to one embodiment of the present invention.
DETAILED DESCRIPTION OF THE INVENTION
• Before the present devices and methods are described, it is to be understood that this invention is not limited to particular embodiments described, as such may, of course, vary. It is also to be understood that the terminology used herein is for the purpose of describing particular embodiments only, and is not intended to be limiting, since the scope of the present invention will be limited only by the appended claims.
• Where a range of values is provided, it is understood that each intervening value, to the tenth of the unit of the lower limit unless the context clearly dictates otherwise, between the upper and lower limits of that range is also specifically disclosed. Each smaller range between any stated value or intervening value in a stated range and any other stated or intervening value in that stated range is encompassed within the invention. The upper and lower limits of these smaller ranges may independently be included or excluded in the range, and each range where either, neither or both limits are included in the smaller ranges is also encompassed within the invention, subject to any specifically excluded limit in the stated range. Where the stated range includes one or both of the limits, ranges excluding either or both of those included limits are also included in the invention.
• Unless defined otherwise, all technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art to which this invention belongs. Although any methods and materials similar or equivalent to those described herein can be used in the practice or testing of the present invention, the preferred methods and materials are now described. All publications mentioned herein are incorporated herein by reference to disclose and describe the methods and/or materials in connection with which the publications are cited.
• It must be noted that as used herein and in the appended claims, the singular forms “a”, “an”, and “the” include plural referents unless the context clearly dictates otherwise. Thus, for example, reference to “a lumen” includes a plurality of such lumens and reference to “the opening” includes reference to one or more openings and equivalents thereof known to those skilled in the art, and so forth.
• The publications discussed herein are provided solely for their disclosure prior to the filing date of the present application. Nothing herein is to be construed as an admission that the present invention is not entitled to antedate such publication by virtue of prior invention. Further, the dates of publication provided may be different from the actual publication dates which may need to be independently confirmed.
• The devices disclosed herein can be used to irrigate and/or suction fluids deep within the sinuses, as well as in other areas within the paranasal space or other locations in the ear, nose and throat anatomy. Devices disclosed herein may also be used to deliver therapeutic substances (e.g., antibiotics, steroids, etc.) to any of the locations mentioned previously, as well as to take cultures from any of those locations.FIG. 1 shows components that are useable together in an irrigation system according to one embodiment of the present application, to perform functions noted above in treatment and/or diagnosis procedures of the ear, nose and throat anatomy.
• Irrigation catheter10 is flexible, so that it can be delivered through the tortuous anatomy, without kinking, for insertion of the distal end portion thereof deep within a sinus cavity or other deep anatomical structure in the ear, nose and throat anatomy. The elongated flexible tube portion is more flexible than currently existing catheters used in the ear, nose and throat space, yet has sufficient wall strength so that the distal end portion can be routed through a guide catheter having a bend up to at least 110 degrees without kinking the tube of theirrigation catheter10. Guide catheters having such bends in the distal end portion are described, for example, in application Ser. No. 11/193,020, as well as other applications incorporated by reference above. The elongated tube portion of irrigation catheter thus comprises a flexible, biocompatible polymer material, such as nylon, polyethylene, polyether ether ketone (PEEK), or polyether block amides (e.g., Pebax) for example, typically Pebax., as described in more detail below. The elongated tube portion is preferably clear so that a surgeon can see materials being delivered from a target location of the distal end of the irrigation catheter, out through the tubular portion and out of the patient, as well as materials being delivered to the target location, out through the distal end portion of the irrigation catheter. This clear tubing also allows for visual trouble-shooting of the device, e.g., should the tubing become clogged, the user can visualize where along the tubing the clog has occurred, etc.
• Irrigation catheter10 is designed so that it does not have to be delivered over a guidewire. Rather,stylet100 is provided that is insertable throughirrigation catheter10 and which facilitates the delivery and positioning of the irrigation catheter as described in more detail below. Accordingly, no exchange procedure is required, such as removing a working tool from an appropriately placed guidewire and then “exchanging” by delivering an irrigation catheter over the guidewire to direct it to a target site to perform irrigation and/or suction. For example, in a procedure where a guide catheter is first inserted intranasally and maneuvered to align a distal tip of the guide catheter with a sinus ostium, this can be followed by inserting a guidewire through the guide catheter and into the sinus opening up from the sinus ostium that the guide catheter is aligned with. One or more working tools can then be passed over the guidewire to perform one or more surgical procedures in the sinus or at the sinus ostium. For example, a balloon catheter may be delivered over the guidewire to locate a working end (e.g., expandable balloon) in the sinus ostium. After expansion of the balloon to dilate the sinus ostium, deflation of the balloon and removal of the balloon catheter from over the guidewire, an irrigation catheter could then be exchanged to pass over the guidewire to perform irrigation, suction etc. at the location of the sinus ostium. However, the withdrawal of the balloon catheter off the guidewire to allow for the exchange is not a simple task. For example, the guide catheter will typically need to be held stationary and also the guidewire will need to be held stationary to maintain the desired distal end position, and the guidewire may need to be held at a location other than where the guide catheter is being held. While holding both of these components stationary, the balloon catheter (or other working device) must be pulled on or retracted, to remove it from its location over the guidewire.
• By providing a system such as that shown inFIG. 1, the precarious exchange process can be eliminated. Instead, a surgeon can simply pull the balloon catheter (or other working device) and the guidewire out in a single step, or one after the other, but with the point being that no care need be taken to retain the guidewire in position as the working device is withdrawn. After removal of the working device and the guidewire, the irrigation system (irrigation catheter10 havingstylet100 inserted therein) can be delivered through the guide catheter to perform subsequent functions at the sinus ostium or within the sinus, e.g., irrigation, suction, substance delivery, retrieve a culture, etc.
• The system ofFIG. 1 also provides advantages for pediatric patients or for adult patients where an ostium dilation is not performed. For example, the irrigation system can be delivered though a guide catheter without first inserting a guidewire and a device to perform an ostium dilation.
• Irrigation catheter10 is configured to irrigate and suction fluids deep within the sinuses, as well as other areas with the paranasal space. Irrigation catheter is sized appropriately to be delivered into adult as well as pediatric sinuses, including maxillary, sphenoid and frontal sinuses.Irrigation catheter10 can also be used to deliver diagnostic or therapeutic substances into the sinuses or other areas in the paranasal space. Examples of such diagnostic or therapeutic substances include, but are not limited to: contrast agents, pharmaceutically acceptable salt or dosage form of an antimicrobial agent (e.g., antibiotic, antiviral, anti-parasitic, antifungal, etc.), a corticosteroid or other anti-inflammatory (e.g., an NSAID), a decongestant (e.g., vasoconstrictor), a mucous thinning agent (e.g., an expectorant or mucolytic), an anesthetic agent with or without vasoconstrictor (e.g., Xylocaine with or without epinephrine, Tetracaine with or without epinephrine), an analgesic agent, an agent that prevents of modifies an allergic response (e.g., an antihistamine, cytokine inhibitor, leucotriene inhibitor, IgE inhibitor, immunomodulator), an allergen or another substance that causes secretion of mucous by tissues, anti-proliferative agents, hemostatic agents to stop bleeding, cytotoxic agents e.g. alcohol, and biological agents such as protein molecules, stem cells, genes or gene therapy preparations.
• Irrigation catheter10 includes an elongated flexible tubing that extends from ahub14 attached at a proximal end thereof to a tapereddistal tip16. One ormore openings18sare provided through a side wall of thetubing12 at a distal end portion (tip portion) thereof, just proximal of the taperedtip16, as more easily seen inFIGS. 2A-2D. Additionally, an axially directed opening18ais provided as an open distal end ofdevice10. Typically at least two or more, typically three or fouropenings18sare provided to direct irrigation spray in different directions radially fromtubing12. More than fouropenings18smay also be provided, but three or four of thetype openings18sdescribed herein have been found to optimize a balance for providing spray circumferentially about the longitudinal axis of thetube12 while maintaining sufficient wall strength of the tubing to prevent kinking, collapsing or other forms of structural failure. Further in this regard,openings18scan be formed in a spiral pattern about thetubing12 as illustrated inFIG. 2C, or other pattern, so that no two openings are aligned with one another in a direction perpendicular to the longitudinal axis L. This helps to maintain the wall strength of thetubing12.
• Side openings18sare provided to create vortices or turbulent flow of irrigation fluid as it is ejected from the side openings. Side openings are placed so as to eject fluid in radially varying directions to produce the turbulent flow vortices in substantially all direction around the circumference of thetubing10 whereside openings18sare located. For those embodiments that have an end oraxial opening18a, this is also designed to produce turbulent flow/vortices, to act in concert with the vortices produced byside openings18s. The turbulent flow/vortices are further propagated when thetubing12 containing theside openings18sdeliver spray in a small anatomical space, such as a sinus cavity, since the spray hits against one or more walls defining the cavity, further disturbing the flow and increasing the turbulence.
• Side openings18sare typically created as circular holes, although other shapes can be formed, including oval openings, slits, other geometrical shapes, teardrop shaped openings, etc.Openings18sare typically cut or punched through the tubing wall in a direction perpendicular to the longitudinal axis of thetubing12. However, openings may be cut or punched in an angled direction (other than 90 degrees) to the longitudinal axis oftubing12. Still further, openings can be cut or punched to have a nozzle-type configuration, where the cross sectional dimension of theopening18son the inner wall oftubing12 is greater or less than the cross-sectional dimension of theopening18son the outer wall oftubing12.
• Hub14 may be provided with a standard luer hub connection that allows a standard syringe to be readily mounted thereto.Hub14 may be made of polyvinyl chloride (PVC), polycarbonate, stainless steel or other biocompatible metal or other rigid, biocompatible polymer, for example.Hub14 can be provided withlow profile wings14wthat allow manipulation, such as torquing, by a user, but which extend only slightly radially from the main body ofhub14 so that suction hosing can be slid thereover and sealed against the hub to draw suction through the hub.
• One or moreradiopaque markers20 may be provided indevice10. For example a radiopaque band is shown in thetip16 ofdevice10 inFIG. 2D.Tip16 is provided with an atraumatic, blunt shape at the distal end thereof, e.g., rounded or otherwise blunted. The proximal end portion oftubing12 may be overlaid with a stiffer layer or tubing to provide strain relief. For example,FIG. 1 showsstrain relief layer22 that extends distally from a location ofhub14, over a proximal portion oftubing12. Strain relief layer is formed of a stiffer material than thematerial forming tubing12. In the example shown,strain relief layer22 comprises heatshrink polyolefin tubing. To reinforce the joint betweenhub14 andtubing12.
• Stylet100 is configured to be slidably received withinirrigation catheter10 and has a predefined length, so that when connected to or mated withirrigation catheter10 in a manner described in more detail below, adistal tip portion106 ofstylet100 extends distally from thetip16 ofirrigation catheter10.FIG. 3A is a partial view of the irrigation system showing thedistal tip106 ofstylet100 extending distally from the distal end oftip16 ofirrigation catheter10. The distal end ofdistal tip106 extends from the distal end ofirrigation catheter10 by a predetermined length, and this predetermined length can be adjusted by various techniques described herein.
• Typically, the flexibility ofstylet100 varies along the length thereof. For example, the proximal portion of theshaft102 is generally stiffer than the distal portion. In the embodiment shown inFIG. 1, aproximal portion102pis relatively stiffest with anintermediate portion102ihaving an intermediate flexibility, and thetip portion106 being relatively the most flexible. Theproximal portion102pis stiffest as this is where the operator pushes from when inserting the stylet into the irrigation catheter and when inserting the stylet and irrigation catheter into a patient. Accordingly, it is desirable to have this portion relatively more stiff to provide better column strength so that the stylet does not buckle or bend when pushing on it form the proximal end.
• Theintermediate portion102iis somewhat more flexible, as this is the portion of the stylet that may be required to pass through a bend in a guide catheter, when the irrigation system is being delivered though a bent guide catheter, and it is desirable that this portion does not plastically deform when it passes through or is located within a bend in a guide catheter.FIG. 3B illustrates an irrigation system having been inserted though aguide catheter90. The angle of the bend of guide catheter30 is measured by the direction that the distal tip extends in, relative to the longitudinal axis L2 of the main portion ofguide catheter90, as illustrated inFIG. 3B.
• Thedistal tip portion106 is still more flexible than theintermediate portion102i. Further, the distal tip portion can be made so that it is shapeable, so that it can be plastically deformed with a bend that facilitates steering thestylet100 as well as theirrigation catheter10 through the tortuous anatomy, thus providing the same advantages that a guidewire has as it is inserted into the anatomy. However, since the distal end of irrigation catheter is proximally adjacentdistal tip106 as it is advanced, this can provide superior ease of delivery of the irrigation catheter, as compared with delivering an irrigation catheter over a guidewire that has already been previously placed, such that the steerability of the distal tip of the guidewire is not available as the irrigation catheter is inserted over the guidewire. For this reason, an irrigation catheter advanced over a guidewire can tend to get caught up, or snag on various formations in the tortuous anatomy as it is advanced over a guidewire, particularly where the tolerances between the inside diameter of the catheter and the outside diameter of the guidewire are relatively large.
• A settable tip can be provided by the inclusion of ashaper wire108 within the proximal portion. For example shaper wire may be a flattened wire made of stainless steel, nickel-titanium alloy, or other biocompatible metal having characteristics allowing the wire to be plastically deformed when bent over by hand by a user.FIG. 3C illustrates a cross-sectional view ofdistal end portion106 in a location whereshaper wire108 extends, taken along section line3C-3C inFIG. 1.Shaper wire108 is encapsulated in thepolymer110 that forms the outer portion of the shaft oftip106.Polymer110 in the distal tip may be softer than the polymer used to form the remainder of the stylet to make it more flexible and/ordistal tip106 may be somewhat smaller in outside diameter and taper gradually to the outside diameter of theintermediate portion102i.
• In the embodiment shown inFIG. 1,intermediate portion12iis formed of flexible polymer beading with no internal or core component.FIG. 3D illustrates a cross section of theintermediate portion12itaken alongsection line3D-3D inFIG. 1. Theproximal portion102pin the embodiment ofFIG. 1 is made of thesame polymer114 as that of theintermediate portion102i, which is somewhat harder thanpolymer110 thereby providing more stiffness.Proximal portion102pis made stiffer thanintermediate portion102iby the use of acore wire116 that has greater stiffness thanpolymer114.Core wire116 has a substantially larger gauge thanshaper wire108 so that it is not readily plastically deformed during use, but provides additional stiffness and column strength toproximal portion102p.FIG. 3E illustrates a cross-sectional view ofproximal portion102ptaken along section line3E-3E inFIG. 1. Although thesame hardness polymer114 may be used, by encapsulating core wire116 (which may be stainless steel, nickel-titanium alloy, or other biocompatible metal having the requisite stiffness properties), this increases the overall stiffness ofproximal portion102prelative to the stiffness ofintermediate section102i. Additionally or alternatively, the polymer used in making theproximal portion102pmay have a greater hardness than the polymer used forintermediate portion102i. Further alternatively or additionally, theintermediate portion102imay include a core wire having a much smaller cross sectional dimension thancore wire116 inproximal portion102p, as this can be used to more easily target the desired stiffness characteristics of theintermediate portion102i, while still making it more flexible thanproximal portion102p.
• FIG. 3F illustrates an example ofdistal tip portion106 having been bent to set abend106bto facilitate steering thestylet100 andirrigation catheter10 during insertion of the irrigation system into a patient. By rotating the stylet having thebend106b, the direction in which the distal end of the stylet points can be varied, thereby facilitating the direction in which the assembly is advanced as it is pushed against the internal anatomy. This is referred to as “steering” the stylet as it is advanced.
• FIG. 3G shows a longitudinal sectional view of a distal end portion ofstylet100 having been inserted throughirrigation catheter10.FIG. 3G shows thatshaper wire108 does not extend to the distal end ofdistal end portion106 as the distal tip is configured to retain flexibility and to not plastically deform as it is bent over during use. The distal tip may include one or moreradiopaque markers122. When located in the flexible portion distal ofshaper wire108,radiopaque marker122 can be provided in the form of a coil as shown inFIG. 3G. This coil configuration maintains the flexibility of the distal tip, so that it does not plastically deform during use, and provides superior flexibility relative to that provided by a marker band. The radiopaque marker may be made of platinum, tungsten, iridium, palladium, silver, stainless steel, nickel, titanium, alloys thereof, or other dense, biocompatible material having similar physical characteristics and which is readily identifiable under x-ray or fluoroscopic visualization. These materials may also be coated with or otherwise include barium sulfate or other radiopaque compounds typically used in the art.
• FIG. 4A is a longitudinal sectional view of portions ofstylet100, showing thecore wire116 running the length ofproximal portion102p,intermediate portion102imade ofpolymer beading102iwithout core wire support, and the distal end portion includingshaper wire108 extending through a proximal portion thereof (better seen in the enlarged view ofFIG. 4B) andradiopaque marker coil122 distal ofshaper wire108.Hub114 includes a maleslip luer connector114sconfigured and dimensioned to be received in femaleslip luer connector14sonirrigation catheter14. Thus,stylet100 can be rapidly and securely connected to irrigation catheter by insertingstylet100 throughirrigation catheter10 untilmale slip connector114sandfemale slip connector14sform a mating, friction fit. The length ofstylet100 is configured so that a predetermined length ofdistal end portion106 extends from the distal end ofirrigation catheter10 when the friction fit is established. The slip fit luer connectors do not require any torquing of thestylet100 relative to theirrigation catheter10 to establish the connection, and thereby provide further assurance that the stylet does not kink, twist, or experience any other undesirable deformation during the connection process. However, theluer connectors14,114 may alternatively be fitted with mating threads, bayonet connection mechanism, ball-detent connectors, or other alternative mechanical connecting mechanisms, if desired.Hub114 may be made from any of the materials described above with regard tohub14.
• FIG. 4B shows an enlarged view of the distal end portion identified bycircle4B inFIG. 4A.Shaper wire108 is located proximally ofradiopaque marker122 and both are surrounded by thepolymer material110 forming the exterior of the shaft ofdistal end portion106.
• FIG. 4C shows an enlarged view of the portion ofstylet100 wherein theintermediate portion102ijoins theproximal portion102pas identified withincircle4C inFIG. 4A. Ajoint reinforcer124 may be provided over the location whereintermediate portion102ijoinsproximal portion102pwhich extends proximally and distally over portions ofintermediate portion102iandproximal portion102pextending from the joint. The joint can be melted together and/or joined with adhesive.Joint reinforcer124 may be in the form of heat shrink tubing, for example.
• In one particular embodiment, thepolymer110 in distal tip portion is Pebax, 55 Durometer hardness and thepolymer114 in intermediate102iand distal102pportions is Pebax, 72 Durometer hardness. The joint betweenproximal portion102pandhub114 may contain an additional layer of polymer, which in this particular embodiment is Pebax, 55 Durometer. However, this layer could also be made of Pebax, 72 Durometer or some other polymer. It should also be noted that the present invention is in no way limited to these specifications of one particular embodiment, as any or all of these specifications may vary in other embodiments. In this particular embodiment, the overall length of irrigation catheter is about 34.5 cm. This length may vary from about 20 cm to about 60 cm or about 30 cm to about 75 cm or about 35 cm up to about 80 cm or about 25 cm to about 45 cm. The opening18ais about 0.038 inches in diameter, although this size may vary from about 0.016 inches to about 0.042 inches.Irrigation catheter10 in this particular embodiment has three side openings orholes18s, helically spaced about 1 mm apart, and each having a diameter of about 0.040 inches, although diameters may range from about 0.025 inches to about 0.045 inches or about 0.040 inches to about 0.050 inches or about 0.045 inches to about 0.060 inches, andopenings18scan be arranged in some pattern other than a helical one. In this particular embodiment, theradiopaque marker20 is located about 0.6 mm from the distal end ofstylet10. Of course this distance may vary, but is a predetermined distance from the distal end ofstylet10, so that a user can visualize the marker and know approximately where the distal end ofstylet10 resides. The inside diameter ofirrigation catheter10 in this particular embodiment is about 0.054″, although diameters may vary, as noted in other examples herein. The outside diameter ofirrigation catheter10 in this particular embodiment is about 0.078″, although diameters may vary in other embodiments.
• The length of thestylet100 is greater than the length ofirrigation catheter10, and is configured so that, whenstylet100 is mated withirrigation catheter10 in a manner as described above, the distal end ofstylet100 extends beyond the distal end ofirrigation catheter10 by a predetermined distance. In this particular embodiment currently being described, the predetermined distance is about 18 mm. However, this predetermined distance may vary in other embodiments. In this particular embodiment,shaper wire108 is about 0.004 inches in thickness and about 0.013″ in width and is made of stainless steel although these dimensions and material may vary in other embodiments.
• The distal end of radiopaque marker coil in this particular embodiment is about 2.5 mm from the distal end ofstylet100 and is formed of a platinum-tungsten alloy, although this dimension and material may vary in other embodiments. The outside diameter of themain shaft102 is about 0.039″, although outside diameters may vary in other embodiments, and will vary according to the inside diameter of theirrigation catheter10 that it is designed to be inserted into. Thecore wire116 inproximal portion102pis about 0.012″ in diameter, although this diameter may vary in other embodiments. In this embodiment,intermediate portion102iis flexible beading of Pebax, 72 Durometer hardness and has a length of about 10 cm, although this length and material may vary in other embodiments.
• FIGS. 5A through 5C illustrate embodiments of an irrigation system in which only a distal portion ofstylet100 is provided to extend from thedistal tip16 ofirrigation catheter10. In these embodiments,stylet portion106 is fixed in thedistal opening18aofirrigation catheter10 and is not removable therefrom to allow irrigation or suction though opening18aas opening18aremains plugged bystylet portion106 during use. Accordingly, irrigation, suction and other functions such as substance delivery, for example, are performed only thoughside openings18s. Further, sincestylet portion106 is not removable, these embodiments do not allowirrigation catheter10 to be alternatively used over a guidewire.Stylet portion106 is shapeable for providing steerability to the irrigation system, and may be made shapeable by any of the same techniques described above with regard to thedistal portion106 of theremovable stylet100.
• Stylet portion may be made of stainless steel, nickel-titanium alloy or other biocompatible metal or polymer that is flexible, but configured to be plastically deformed, so thatportion106 can function in steering the irrigation system through the tortuous anatomy. Stylet portion may extend from the distal end of irrigation catheter by a length of about one cm to about six cm, for example. An extension length of about four cm may be suitable for accessing a frontal sinus of a patient, an extension length of about one to two cm may be suitable for accessing pediatric maxillary sinuses.Distal stylet portion106 can also be provided with aradiopaque marker122 that can provide a fluoroscopic visualization to indicate the location of the side holes18sofirrigation catheter10, as the user will know the predetermined distance between such marker and theside openings18s. Other placements of radiopaque markers can be made for this function as well, as described in more detail below. In the embodiment shown inFIG. 5A, asingle lumen26 is provided in irrigation catheter through which both irrigation and suction can be performed, as well as other functions including, but not limited to delivery of diagnostic or therapeutic substance, and taking cultures.FIGS. 5B-5C illustrate an embodiment in whichdedicated lumens26₁and26₂are provided for performing suction and irrigation simultaneously.FIG. 5B illustrates one side of a distal portion of the irrigation system showing an end opening26oin fluid communication withlumen26₂andFIG. 5C shows the opposite side of the distal portion of the irrigation system ofFIG. 5B showingside openings18sin fluid communication withlumen26₁.
• Theside openings18scan be varied in diameter, number and arrangements as already noted. Relatively small numbers, e.g., about one to ten of relatively larger diameter holes are preferred over large numbers, e.g., greater than twenty, greater than fifty or greater than one hundred holes having relatively smaller diameters, as both sets of these arrangements were found to be effective for irrigation, but the arrangements with smaller numbers of larger holes provided an advantage for suction, since large particles of debris can be taken up through the large holes. However, the arrangements having larger numbers of smaller diameter holes are not excluded from this disclosure. In another embodiment, an arrangement of fourside holes18seach having about 0.050 inch diameter and being equally distributed around the circumference of the irrigation catheter tip16 (at a location where catheter tip is not tapering down, but has the full diameter of the remainder of the shaft102). Whenirrigation catheter10 is connected to a syringe (having a volume of about 10 cc to about 60 cc, for example), an irrigation stream can be delivered that can vary in pressure from a gentle rinse to a vigorous wash, depending upon the amount of pressure applied to the plunger of the syringe by the user.
• In one embodiment,distal stylet portion106 is made of a coil made of a core wire of stainless steel of about 0.025 inch diameter and irrigation catheter is made from Pebax, 55 Durometer hardness. A polyimidestrain relief tube22 of the type described above with regard toFIG. 1 is provided that has about 0.0015″ wall thickness. Aluer hub14 is mounted to the proximal end ofirrigation catheter10 in the same manner as described above.
• One of the design challenges for theirrigation catheter10 is to provide theirrigation catheter10 to be guided around a bend in a guide catheter, wherein the bend is up to at least about 110 degrees, measured as described above, without kinking occurring in thetubing12 of theirrigation catheter10. One way to address this concern is to increase the wall thickness of the polymer material forming thetubing12 so that is strong enough not to kink. Another approach is to reinforce the polymeric wall of thetubing12, such as by including a coil, braided tubing, spiral cut tubing, or other reinforcingstructure28 within (between) the inner and outer wall surfaces of thetubing12. An advantage to using a reinforcingstructure28 is that it enables the overall wall thickness oftubing20 to be made thinner than one made solely of polymer, in order to attain the same strength/kink resistance. This is advantageous since the outside diameter oftubing12 is constrained to a limit to enable it to be passed through a guide catheter, for example, while it is also of interest to maintain the inside diameter oftubing12 as large as possible to maximize the ability to transport fluids therethrough. The resistance to flow within a tube is proportional to the length of the tube and inversely proportional to the fourth power of the inside diameter of the tubing:
• $\mathrm{Resistance}\propto \frac{\mathrm{Length}}{{\mathrm{ID}}^4}.$
• Accordingly, since the outside diameter of the design is constrained, it becomes very important to minimize the wall thickness, as small increases in the inside diameter can have a great reducing effect on the resistance. In two specific embodiments, atubing12 made of Pebax and having a wall thickness of about 0.012″ was sufficient to prevent kinking, for an outside diameter of about 0.078″, when the tubing was passed through a guide catheter having a 110 degree bend. A coil reinforcedPebax tubing12 having the same diameter had a wall thickness of about 0.008″ and prevented kinking when being passed through the guide catheter having the 110 degree bend.
• FIG. 6A illustrates one configuration for providing a reinforced tubing wherein reinforcing structure (a coil in the example shown inFIG. 6A) is sandwiched between two layers of polymeric material, andinner tube12iand an outer tube12o. Alternatively, reinforcingstructure28 can be molded within the polymeric wall oftube12, as illustrated inFIG. 6B. In the example shown inFIG. 6B, polymer tubing is molded with reinforcingstructure28 therein to encapsulate the same between inner and outer wall surfaces of a singletubular structure12. The reinforcing structure is present only in a portion oftube12 proximal ofside openings18s, with the section containing theopenings18sconsequently being radiolucent. However, by visualizing the coil, where the coil is a radiopaque metal, an operator can locate the side openings, knowing that they are placed just distal of the distal end of the reinforcingstructure28.
• Also, in this embodiment, the distal tip, stylet-like portion106 is metal wire and also radiopaque. The combination of reinforcingstructure28 anddistal tip portion106 outlines the radiolucent section that corresponds to theopenings18s. Thus, under fluoroscopic, or other x-ray visualization, theopenings18scan be located by a “negative” type of visualization, i.e., the gap that shows up between the visualization of thesupport structure28 anddistal tip106.
• FIG. 6C illustrates an embodiment where a flat coil orspiral ribbon28 structurally reinforcestubing12, including the portion oftubing12 in whichside openings18sare formed. Reinforcingstructure28 is sandwiched between two layers ofpolymer12oand12iinFIG. 6C, but a similar arrangement can be made by encapsulating reinforcingstructure28 in asingle polymeric tubing12. In order to provide adequate spacing for forming side holes18sbetween windings or coils of reinforcingstructure28, the windings or coils of reinforcing structure can be pulled apart to increase the pitch/distance between coils/windings28w2 in the locations whereside opening18sare to be formed, relative to the pitch/distance28w1 between coils/windings in the remainder of reinforcingstructure28.FIG. 6D illustrates coils at a distal end portion of reinforcing structure having been pulled apart to increase the distance between windings, and locations where the side openings are to be formed are indicated by thecircles18s. Side holes18smay be punched throughtubing12, such as by laser drilling, or other known techniques. In one particular embodiment, thelayers12oand12ioftubing12 comprise 55 durometer Pebax and reinforcingstructure28 is a stainless steel coiled ribbon of thickness about 0.002″ and width about 0.012″ and the pitch28w1 is about 0.008″. Pitch28w2 is an expanded width permitted aside hole18shaving a diameter or about 0.040″ to be punched intubing12.Tip106 is 304V stainless steel having a length of about four cm. The inside diameter oftubing12 is about 0.081″ and the outside diameter oftubing12 is about 0.096″.
• Alternative to the use of awire tip106, a polymeric tip can be used. One advantage of using a polymeric tip, is that it can be trimmed by a surgeon to customize the length that the distal tip, stylet-like portion106 extends from the distal end ofcatheter10. Whereas use of thewire tip106 provides only a single predetermined extension distance, use of apolymeric tip106 allows the extension distance to be customized by the surgeon, by clipping a portion of thetip106 to change the length thereof, and thus change the distance by which the distal end oftip106 extends from the distal end ofcatheter10.FIG. 7A illustrates one example wherein apolymer tip106 extends originally by a predetermined distance of P1, and whereintip106 has been clipped at106cto customize the extension length to P2. Examples of polymers that can be used to make stylet-like tip106 include, but are not limited to: Pebax, polyurethane, and Nylon. A material should be chosen so that the trimmed tip does not have sharp, traumatic edges, but maintains an atraumatic contour, similar to the distal end of theuntrimmed tip106.
• Further alternatively,tip106 may be formed by a thinmetal wire core106ecovered bypolymeric material106pas illustrated in the enlarged cross-sectional view inFIG. 7C taken alongsection line7C-7C of the irrigation system partially illustrated inFIG. 7B.
• FIG. 7D illustrates an irrigation system having a clippable stylet, distalend tip portion106 extending distally from a distal end ofirrigation catheter10. In this embodiment,radiopaque markers20 are intermittently placed betweenpolymeric sections106poftip106 so thatradiopaque markers20 andpolymeric sections106palternate in an axial direction (distal to proximal or proximal to distal) along thetip106. Accordingly, when a user clips a portion oftip106 to adjust the length thereof, at least one radiopaque marker typically remains in the clippedtip portion106 that remains connected to theirrigation catheter10.Phantom lines106c1 and106c2 indicate two exemplary locations wheretip106 can be clipped and where at least oneradiopaque marker20 remains in place on the attached, clippedtip portion106. Of course these are only two examples, astip106 can be clipped at any locations along thepolymeric sections106p. If the user accidentally clips at the location of a radiopaque marker and the clipping operation is not successful, the user can make another clip just proximal of that radiopaque marker. To increase the adjustability or ability to customize the length oftip106, a kit of irrigation systems may be provided whereinirrigation catheter10 is essentially the same in each system, but wherein the pattern ofradiopaque markers20 andpolymeric section106pvaries among the different systems in the kit.FIG. 7E illustrates threedifferent tip arrangements106 as non limiting examples of those that can be included in a kit. Tips may be integrally formed each on its own irrigation catheter. Alternatively,tips106 may be provided withthreads106tat the proximal end of each that are mateable with threads16ton the inside surface of the distal end opening inirrigation catheter10, as illustrated inFIG. 7F. In this case, atip106 can be removed fromirrigation catheter10 by unscrewing it, and atip106 having another arrangement ofradiopaque markers20 andpolymeric sections106pcan be installed in its place by screwing it into the distal end opening ofirrigation catheter10.
• Radiopaque markers20 may be stainless steel, tungsten, or other metal or dense material that is readily visible under fluoroscopy. Polymer sections may be made of any of the various polymers described previously for makingtip106. In one particular embodiment, radiopaque markers are 0.020″ in diameter and an inner mandrel of polymer formingpolymeric sections106pis Barium-loaded Pebax, with the Pebax having a hardness of from about 35 to about 50 durometer, Shore hardness.Markers20 may have a length of about two to about six mm, typically about three to about 5 mm, and in two particular embodiments, had lengths of 3 mm and 6 mm respectively. Both theradiopaque markers20 and the polymeric inner mandrel sections10pcan then be coated by an external layer or outer jacket of polymer to form a smoothintegral tip106. In one particular embodiment, the outer jacket is Barium-loaded Pebax, with the Pebax having a hardness of from about 35 to about 50 durometer, Shore hardness.
• Various marking configurations can be used to facilitate fluoroscopic visualization of the location of theside openings18sinirrigation catheter10. For example, a radiopaque marker band (e.g., platinum or iridium band, or the like) can be located on or within thetubing wall12 proximally adjacent the proximalmost side opening18sas illustrated inFIG. 8A. Additionally, in this embodiment,stylet tip portion106 is metallic (e.g., stainless steel or the like) and functions as a radiopaque marker. In an embodiment of the type employing aremovable stylet100, such as like that shown inFIG. 1, amarker20 can be located the same as shown inFIG. 8A, and anotherradiopaque marker20 can be located distally adjacent the distalmost side opening18s, for example, in the manner shown and described above with regard toFIG. 2D. A similar arrangement can be provided in a system of the type shown inFIG. 8A, as illustrated inFIG. 8B, wherein dualradiopaque markers20 are sandwiched in between layers of Pebax forming thetubing12, at locations proximally adjacent the most proximally located side opening18sand distally adjacent the most distally located side opening18s, respectively.
• FIG. 8C illustrates another marking configuration, whereintip106 is metallic and therefore substantially radiopaque, and aportion12boftube12 that is proximal of the most proximally located side opening18sis barium-loaded, to provide radiopacity. For example, thisportion12bof tubing can be formed by extruding barium-loaded polymer. The entire length of tubing proximal of theside openings18scan be barium-loaded, or only a band of tubing just proximal of theside openings18scan be barium-loaded, with the remaining portion of tubing proximal of the barium loadedsection12bbeing made of radiolucent polymer. Alternatively, the portion oftube12 containing side holes18smay be barium loaded, in which case theportion12bshown inFIG. 8C would then be barium free and radiolucent. In this alternative arrangement,tip106 can also be made of radiolucent polymer. However, even with ametallic wire tip106, a barium loaded section oftubing12 containing the side holes18smay still be distinguishable fromtip106 because of its substantially greater width in the visualization.
• FIG. 8D illustrates another configuration in which aplatinum coil20 is located within the distal tip ofirrigation catheter10 around a proximal end ofstylet tip portion106. Additionally, aradiopaque marker20 is located near a distal end oftip106. This marker may be a platinum, stainless steel or tungsten coil, for example, or may be a polymer segment that is barium-loaded, for example.
• FIG. 8E shows another example in which a radiopaque marker is extends along substantially the entire length oftip106,Marker20 may be a coil of the type described above with regard toFIG. 8D, or may be astylet shaft106bthat is formed entirely of barium-loaded polymer, such as barium-loaded Pebax for example. The arrangements described herein are merely for exemplary purposes and are not meant to be exhaustive of all marking configurations that could be used. Further, features of the various embodiments described above may be combined with features of other marking configuration embodiments where possible.
• FIG. 8F illustrates an irrigation system having a removable stylet, wherein a radiopaque marker band is embedded indistal end portion16 ofirrigation catheter10 and a radiopaquemetallic coil20. (e.g., platinum marker coil) is embedded in thedistal end portion106 ofremovable stylet100. Note that the tolerance between the outside diameter ofstylet100 and the inside diameter ofirrigation catheter10 is not shown to scale for purposes of more clearly showing the components. In one particular embodiment, when the slip luer features ofhubs14 and114 are mated as shown inFIG. 8F, the distal tip ofstylet100 extends from the distal tip of irrigation catheter by a distance P1 of about 1.5 cm. As noted earlier, the desired predefined distance may vary, depending upon the particular anatomy that is to be accessed (e.g., frontal sinus versus maxillary sinus) the patient type (e.g., male vs. female, adult vs. pediatric) or even the particular patient. Accordingly a series or kit ofstylets100 may be provided having varying lengths so that, when installed inirrigation catheter10, the predetermined distance P1 varies. Thesestylets100 can be color coded to differentiate between the different lengths, e.g., by colored bands provided on the stylets.
• Alternatively, the predetermined distance P1 may be made adjustable by the provision of astylet100 that can be adjusted, relative toirrigation catheter10, so thatstylet100 and irrigation catheter can be mated so that the distal end ofstylet100 extends beyond a distal end of irrigation catheter by a predetermined distance that can be selected by the user, within a range of predetermined distances that the system is adjustable to achieve. In one embodiment, one ormore spacers1114 are provided that interconnect between the mating components ofirrigation catheter10 andstylet100 to reduce the predetermined length by which the stylet tip extends from the irrigation catheter tip. For example, when the mating components are male and female slip luer connections as described above,spacer1114 can be formed as a stackable luer hub having amale slip taper1114mfor mating with the female luer taper of the mating components of the system (onconnector14 ofirrigation catheter10, in the examples shown, although the female taper could alternatively be onconnector114 of stylet100), and afemale slip taper1114ffor mating with the male luer taper of the mating components of the system.
• FIG. 9A illustratesstylet100 mated withirrigation catheter10 via luer slip mating such that the distal end ofstylet100 extends beyond the distal end ofirrigation catheter10 by a predetermined distance P1.FIG. 9B illustrates a spacer having been inserted between the mating surfaces ofhubs14 and114, so that male luer taper114mmates with the female luer taper ofconnector14 andfemale luer taper1114fmates with the male luer taper ofconnector114. When all components are securely mated, the predetermined distance P2 by which the distal end ofstylet100 extends from the distal end ofirrigation catheter10 is less than predetermined distance P1 by an amount equal to thedistance1114pby which spacer1114 separates thehubs14 and114 from their relative positions when directly mated without the use of aspacer1114. That is, P1−1114p=P2.Spacers1114 of varying length can be provided in a kit to allow a user to select aparticular length1114pby which to shorten the predetermined length P1. Additionally,spacers1114 can be labeled with pre-calculated, predetermined lengths that result from their use with a particular irrigation system, so that the user does not have to calculate P1−1114p=P2 for each spacer, but can just select from the pre-calculated P2 values that are labeled on thespacers1114. Additionally,spacers1114 may be color-coded with different colors relative to one another, for easier identification and selection of a particular spacer to use. Still further,spacers1114 are stackable, so that more than onespacer1114 can be mated in between thehubs114 and14. In such a use, the reduction in the predetermined distance is equal to the sum of the individual distances by which each of thespacers1114 used would reduce the length of the predetermined distance when used alone. In one example, spacers are provided havingreduction lengths1114pin five mm intervals, e.g.,1114p1=5 mm,1114p2=10 mm,1114p3=15 mm, etc, and are color-coded by length. Of course, kits ofspacers1114 may be provided in other series of varying lengths, and the incremental changes in lengths between spacers need not all be the same.
• Spacers1114 have alumen1116 that extend therethrough to allow thespacer1114 to be slid over the shaft of thestylet100 prior to insertion of thestylet100 intoirrigation catheter10. Alternatively,spacer1114 may be provided with aslit1116sthat extends through the wall of the spacer and extends the length of the spacer to provide an access opening to lumen1116, as illustrated inFIG. 9C and the end view ofFIG. 9D. With this configuration,stylet100 can already be inserted into irrigation catheter whenspacer1114 is inserted. All that is required is thathub114 be space proximally fromhub14 to expose a portion ofstylet shaft102 of sufficient length to allow spacer to be slid thereover, so thatshaft102 passes thoughslit1116sand intolumen1116. This is advantageous, particularly where it becomes desirable to exchange onespacer1114 for another, or to add aspacer1114, as it does not require complete removal ofstylet100 fromirrigation catheter10 and then reinsertion ofstylet100 into irrigation catheter each time one of these function is performed.
• FIG. 9E illustrates another embodiment of a spacer that has anadjustable length1114p. The adjustable length is achieved by one ormore telescoping components1118 that are slidable (telescoping) with regard to a fixed portion of thespacer114. For example, thetelescoping portions1118 inFIG. 9E are axially slidable with respect to the fixed distal end portion that includes themale luer taper1114m.Telescoping portions1118 can be individually slid apart, so that spacer1114 is variably adjustable to more than one adjusted length. When atelescoping portion1118 has reached the end of its axial travel in either direction, it forms a friction fit with the component that it has slid relative thereto, thereby maintaining that axially extended (or compressed) end position. Alternatively, a locking mechanism can be provided between telescoping components, one example of which is illustrated in the sectional view ofFIG. 9F. In this arrangement, one of the components (atelescoping portion1118 as shown, although it could be a fixed portion ofspacer1114 that atelescoping portion1118 slides relative to) is provided with agroove1120 and the component that it slides relative to (anothertelescoping portion1118 or a fixed portion) is provided with a protrusion orpeg1122 that fits ingroove1120 and is slidable therein.Groove1120 extends axially over a distance equal to the extent (distance) that thetelescoping portion1118 can slide away from the other component. At proximal and distal end ofgroove1120, groove changes directions to extend in a direction perpendicular to the axially extending portion. Thus, when telescoping portion is in its most collapsed configuration, it can be rotated to placepeg1122 in a portion ofgroove1120 that extends perpendicular to the axial direction, thereby preventing axial movements oftelescoping portion1118 relative to the other component. To unlock thetelescoping portion1118, it can be rotated in the opposite direction to alignpeg1122 with the axially extending portion ofgroove1120.Telescoping portion1118 can then be pulled away from the other component as peg slides along the axially extending portion ofgroove1120 untilpeg1122 abuts against the end of the axially extending portion ofgroove1120.Telescoping portion1118 can then be rotated again in the first direction to drivepeg1122 into the portion ofgroove1120 that extends perpendicular to the axial direction at the opposite end, thereby lockingtelescoping portion1118 in the extended configuration. This mechanism can be provided for eachtelescoping portion1118 so that each telescoping portion can be individually locked, unlocked and axially slid.
• FIG. 9G illustrates another embodiment of an axiallyadjustable spacer1114. In this configuration, the distal1114aand proximal1114bportions ofspacer1114 that include the mateable male and female tapered luer surfaces114mand1114fare interconnected by anadjustment member1124. InFIG. 9G, theadjustment member1124 comprises a screw threaded shaft that is fixed to one of thecomponents1114aand114band is threadably mated with the other component. Thus, by rotating one of theportions1114a,114brelative to the other, this causesadjustment member1124 to screw into the component that it is threadably mated with or to screw out of it, depending on the direction of rotation. These actions change the overall length ofspacer1114 and thus thedistance1114pby which the spacer reduces the predetermined length of the distal tip of thestylet100 past the distal end ofirrigation catheter10. Although not shown inFIG. 9G,adjustment member1124 includes anaxially extending lumen1116 that communicates withlumen1116 in the remainder ofspacer1114 so that spacer1114 can be slid overstylet shaft102. This embodiment can also include aslit1116sas described above, and as illustrated inFIG. 9H, so that this embodiment ofspacer1114 can be installed without having to removestylet100 completely fromirrigation catheter10.
• FIG. 9I illustrates an embodiment of an irrigation system in which a predetermined distance of extension of the distal tip ofstylet100 beyond a distal end ofirrigation catheter10 is adjustable. In this embodiment, anadjustment member1124 of the type described with regard toFIGS. 9G and 9H above is built intohub114 ofstylet100. Accordingly, rotation of the knob orproximal end portion114bofhub114 relative to thedistal portion114acause the separation between these portions to either increase or decrease, depending upon the direction of rotation, and consequently either decrease or increase the predetermined distance, respectively. In this case,adjustment member1124 need not have axially directedlumen116 as theshaft102 ofstylet100 can be connected at thedistal portion114aofhub114.Hub114 may be configured with detents, so that the mechanism “clicks” or when a separation distance betweencomponents114aand114breaches a distance that may be particularly interesting to the user. For example, clicking may occur at increments of every 10 mm or some other predefined click distances. Additionally or alternatively,adjustment member1124 and/ordistal tip portion106 may be provided withindicators markings1126 that visually indicate to the user when a particular predetermined distance has been reached.
• FIG. 9J shows a variation of the arrangement ofFIG. 9I in which theadjustment member1124 has been is built intohub14 ofirrigation catheter10, between distal andproximal portions14aand14b. In this case,adjustment member1124 has anaxial lumen116 to allowshaft102 to pass therethrough and slide with respect toadjustment member1124.
• As noted above, thedistal tip portion106 has an atraumatic distal end or tip, which, for example, may be rounded or some other blunt configuration to prevent damage to tissues that it runs up against during insertion of the stylet. This is the same, whetherdistal tip portion106 is a portion of aremovable stylet100 or is fixed at the distal end of irrigation catheter. The further characteristics described below are also applicable to bothremovable stylet100distal end portions106 as well as distal end portions that are fixed to the irrigation catheter.
• At least the distal portion of thedistal tip portion106 is flexible, so that when thetip106dcontacts and obstruction900, thedistal tip portion106 bends over, as illustrated inFIG. 10A, rather than acting as a spear point. This flexibility also allowstip106dto reorient at thedistal tip portion106 bends, providing it an opportunity to find a pathway where it can be further advanced, rather than simply being obstructed by the obstruction900 with no way to change direction. Further, the bend should be a gradual bend, as shown, as thedistal tip portion106 should not kink, but bend gradually when abutting an obstruction.
• At least a portion of thedistal tip portion106 that extends beyond the distal end ofirrigation catheter10 is also shapeable. The term “shapeable” is used to refer to the ability of a user to impart a bend or curve on the tip via plastic deformation, so that the curve or bend is retained in thetip portion106 after release of bending force by the user, as illustrated inFIGS. 3F and 10B. This curve or bend106bthat is set into the distal end portion improves the ability to steer thedistal end portion106 as the irrigation system is advanced through the tortuous or branching anatomic pathways, since by rotating the system, this changes the direction in which the bent tip points and facilitates directing it in one particular direction or another.
• Additionally, thedistal tip portion106 is supportive. That is, although it is sufficiently flexible to bend when directly contacting an obstruction900, as described with regard toFIG. 10A, when it is steered into apassageway902 and obliquely contacts awall904 defining thepassageway902, as illustrated inFIG. 10C, distal tip portion is sufficiently stiff to steerirrigation catheter10 into thepassageway902, as illustrated inFIG. 10D, rather than flopping over or prolapsing whenirrigation catheter10 is pushed on from a proximal location to drive the irrigation catheter into the passageway.
• These conflicting design goals can be achieved according to the various embodiments for design of adistal tip portion106 described herein, such as described in one embodiment with regard toFIGS. 4A-4C, for example.FIGS. 11A-11D illustrate another embodiment of adistal tip portion106 of astylet100 that satisfies the flexibility, shapeability and supportive requirements described above. As already noted, this design, like others described herein is equally applicable to adistal tip portion106 of a removable stylet, as well as adistal tip portion106 fixed to a distal end of anirrigation catheter10.
• FIG. 11A is a longitudinal sectional view ofdistal tip portion106 and a distal portion of an intermediate segment ofstylet100 joining distal tip portion, with a distal end portion ofirrigation catheter10 shown in phantom lines. In this embodiment,shaper wire108 is provided with varying cross sections so that the bending strength increases in a direction from the distal end ofshaper wire108 to the proximal end. In the example shown,shaper wire108 has three sections of varying cross-sectional dimension which directly varies the bending strength of each section. However, shaper wire can be formed in more or less than two sections of varying cross section. Further alternatively,shaper wire108 can be formed with a constantly varying cross-sectional area over all or a portion of the shaper wire so that the bending strength varies constantly over such length.
• In the embodiment shown,section108d, the distal most section that extends distally of the distal end ofirrigation catheter10 has the relatively smallest cross-sectional area to provide the relatively greatest amount of flexibility and to allow a shape to be readily set.FIG. 11B shows a full cross-sectional view ofdistal tip portion106 taken at a location indicated byarrows11B-11B on the sectional view ofFIG. 11A. Theintermediate section108ihas a relatively larger cross-sectional diameter than thedistal section108d, as clearly shown by comparingFIGS. 11A and 11C, and a relatively smaller cross-sectional diameter than that ofproximal section108p, shown inFIG. 11E. In this embodimentdistal section108dis flattened into a ribbon having a thickness t1,intermediate section108iis flattened into a ribbon having a thickness t2 that is greater than t1 andproximal section108pmaintains a circular cross section, with a thickness or diameter t3 greater than t2.
• The proximal end ofdistal tip portion106 joins the proximal end ofintermediate portion102iat a location that is inside ofirrigation catheter10 for embodiments using aremovable stylet100, as shown inFIG. 11A. This helps with supportive properties as the distal en ofirrigation catheter10 aids in providing support and reinforces the joint betweendistal tip portion106 andintermediate portion102i.
• In one particular embodiment,shaper wire108 is made from 0.008″ stainless steel wire and flattenedportions108dand108ihave thicknesses t1 of about 0.02″ and t2 greater than about 0.02″ but less than about 0.08″. Theouter polymer jacket110 comprises an 0.08″ thick wall of Pebax tubing of 40 durometer Shore hardness.Marker coil122 is platinum or tungsten and has an outside diameter of about 0.16″, a length of about 5 mm and is formed of a coil wire having a wire diameter of about 0.02′ to about 0.03″. The intermediate (and proximal (not shown inFIG. 11A))portions102iand102pare formed of Pebax beading having a Shore hardness of 72 durometer.Ribbon108dis thin and wide for increased shapeability and flexibility in one plane.
• FIG. 12 illustrates an arrangement for delivering high pressure irrigation to an anatomical site within a patient. In a standard irrigation procedure, where a syringe (e.g., having a volume of about 10 cc to about 60 cc, for example) is used to drive the irrigation fluid out of theopenings18s(and optionally,18a) by hand pressure by the operator on a hand pushable plunger of the syringe, fluid pressures of about 4 to about 6 pounds per square inch (psi) are typically generated when using a 60 cc syringe, and pressures of about 15 to about 25 psi can be generated using a 10 cc syringe. In the example shown inFIG. 12, an irrigation system comprising anirrigation catheter10 having an integrated styletdistal tip portion106 is used. It is noted that an irrigation system comprising anirrigation catheter10 andremovable stylet100 could be substituted to also perform high pressure irrigation. After maneuvering the irrigation system through the tortuous anatomy, either with our without use of a guide catheter, and steering the system throughsinus ostium906 by steering thedistal tip portion106 as described above, withirrigation catheter10 is advanced, followingdistal tip portion106 intosinus908 and delivered deep into thesinus908 as shown inFIG. 12.
• The Luer connector ofhub14 is connected to ahigh pressure valve300 in fluid communication therewith, which is in turn connected to a highpressure inflation device320 viaconduit322. As shown, highpressure inflation device320 comprises a screw-threaded pump of a type that can be used to inflate balloon catheters, and has a screw-threaded plunger that can be torqued (or, alternatively, a rack and pinion driving mechanism can be substituted) to develop high pressure withinreservoir324 that contains an irrigation fluid (e.g., saline or other irrigating fluid used in ear, nose and throat practice), and locked vialocking mechanism330 to maintain the high pressure until it is released by openingvalve300. Other types of high pressure pumps could be substituted, including motor-driven pumps. A pressure valve332 can be provided in fluid communication withreservoir324 to provide feedback to the user as to how much pressure is developed in the chamber/reservoir prior to releasing the irrigation spray.
• In the example shown,valve300 is a high pressure push-button valve that is normally closed, but opens upon depressing push-button302. Of course, other alternative types of valves can be substituted here as long as they are rated for sufficiently high pressure and are operable between closed and open states. Once the distal end portion ofirrigation catheter10, includingside openings18s, has been appropriately placed in a target where it is desired to perform the high pressure irrigation, such as deep in thesinus908 in the example shown inFIG. 12, pressure is built up inchamber324 by advancingplunger326, whilevalve300 remains closed. Once sufficient pressure has been established in chamber324 (e.g., pressures of about 50 to 100 psi, or about 100 to 150 psi, or about 150 to 300 psi, or pressures greater than about 25 psi can be generated),valve300 is opened, such as by depressingbutton302 in the example ofFIG. 12, and a high pressure spray is impulsively driven and jest out ofside openings18s, developing vortices of flow in directions circumferentially aroundtubing12 to provide a scrubbing type of wash to the walls of the ostium. This enable a surgeon to direct a high-pressure jet inside thesinus cavity908 to remove debris, mucus, fungus, etc.
• FIG. 13A illustrates another embodiment of an irrigation system in whichirrigation catheter10 has an integrated styletdistal tip portion106.Distal tip portion106 hasradiopaque markers20 at intermittent locations along an axial length thereof and a proximal end portion of distal tip portion is joined within thedistal end portion16 ofirrigation catheter10. In one particular embodiment according to this arrangement, the proximal end portion ofdistal tip portion106 is received in irrigation catheter to a length of no greater than about three mm,distal tip portion106 is made of 55 durometer Pebax and has an outside diameter of about 0.35″,radiopaque markers20 are platinum coils made from platinum wire with the coils having a length each of about 2 mm and four side holes each having a diameter of about 0.50″ are punched incatheter tubing12 adjacent the distal end ofirrigation catheter10, whereintubing12 is made of 55 durometer Pebax having a wall thickness of about 0.13″. In an embodiment having adistal tip portion106 about 20 mm long, twoplatinum coils20 are placed, as shown inFIG. 13A. For an embodiment having adistal tip portion106 about 40 mm long, three platinum coils30 are spaced substantially equidistantly apart in the shaft ofdistal tip portion106. In an alternative embodiment,distal tip portion106 is formed of 55 durometer, barium sulfate-filled Pebax and aplatinum coil20 having a length of about 8 to 10 mm long in placed in thedistal tip portion106. Alternatively,markers20 can be made of stainless steel, or tungsten, or of any of the other materials mentioned previously.
• FIG. 13B illustrates an embodiment in whichdistal tip portion106 is about 30 mm long. A polymer inner core is provided (e.g., solid Pebax, 55 durometer having a diameter of about 0.20″ to about 0.22″) and a metallicradiopaque coil marker20 is wrapped around the inner core. In one particular embodiment, the marker is a stainless steel coil having a diameter of about 0.22″. In another particular embodiment, the marker is a tungsten coil having a diameter of about 0.22″ to 0.24″. An outer layer of Pebax encapsulates the core andmarker20 to give the distal tip portion an outside diameter of about 0.35″. An additionalradiopaque marker20 is provided in the proximal end portion ofdistal tip portion106 in the form of a marker band, in this case a platinum marker band having an outside diameter of about 0.30″ to about 0.36″.
• FIG. 13C illustrates an embodiment havingsimilar tubing12 to previously described embodiments, and having adistal tip portion106 the extends form the distal end ofirrigation catheter10 by a length of about 12 mm.Distal tip portion106 is soft and shapeable, and made of 55 durometer Pebax, with aplatinum marker coil20 extending about 10 mm from the distal end ofirrigation catheter10. The Pebax polymer ofdistal tip portion106 is melted over the marker coil during production, so thatmarker coil20 is engulfed by the polymer material. Axially adjacent side holes18sin this embodiment are separated by an axial distance of about 7 mm, and threeside holes18sare provided, each having a diameter of about 0.50″. It is again noted here that these specification are for one particular embodiment, and that the arrangement shown inFIG. 13C is not limited to these specifications, as the specifications may vary, for example, as noted by the remainder of the disclosure herein, or by other equivalent variations.
• FIG. 13D illustrates an embodiment wheredistal tip portion106 includes a solid polymer tip that contains aradiopaque coil20 at a distal portion of thedistal tip portion106.
• FIG. 14 illustrates a removable illuminatingstylet100 that includes an illuminatingdistal tip106iat a distal end of thedistal tip portion106. One or more illumination channels10iare provided instylet100 and extend the length thereof. Illumination channels10iare configured to transport light from the proximal end ofstylet100 to and out of thedistal end106i. In the example shown, two illumination channels are provided, each comprising a plastic illumination fiber. The plastic used to make the illumination fibers is compounded for light transmission properties according to techniques known and available in the art. As one example, ESKA™ (Mitsubishi Rayon), a high performance plastic optical fiber may be used, which has a concentric double-layer structure with high-purity polymethyl methacrylate (PMMA) core and a thin layer of specially selected transparent fluorine polymer cladding.
• Alternatively, a single plastic illumination fiber10imay be used, or glass illumination fibers may be substituted which are much smaller in outside diameter, e.g., about 0.002″. In this case, more illumination fibers may be provided in a bundle.
• The distal end ofstylet100 can be sealed by a transparent (or translucent)seal106iwhich may be in the form of epoxy or other transparent or translucent adhesive or sealing material.Seal106imaintains the distal ends of illumination fibers10icoincident with the distal end ofstylet100 and also provides an atraumatic tip of thedevice100. Further, seal106iprevents entrance of foreign materials into the device. The distal end can be designed to either focus or distribute the light as it emanates therefrom, to achieve maximum transillumination effects. In this regard, the distal end can include a lens, prism or diffracting element.
• The proximal end oftubing102 can also be sealed by a transparent (or translucent) seal which may be in the form of epoxy or other transparent or translucent adhesive or sealing material. This proximal end seal maintains the proximal ends of illumination fibers10icoincident with the proximal end ofstylet tubing102. The proximal end ofdevice10 maybe further prepared by grinding and polishing to improve the optical properties at the interface of the proximal end ofstylet100 with a light source.
• Alight source1030 is connected to stylet100 viahub14 in this case which is also configured as an optical connector. The couplet ofhub14 is connected tolight source1030, such as a conventional endoscope light source, for example, or other light source capable of delivering preferably at least 10,000 lux throughhub14. Light cable1032 optically connects the connector ofhub14100 withlight source1030 to deliver light from thelight source1030 tohub14. Light cable1032 can optionally be a fluid-filled light cable, such as the type provided withDYMAX BlueWave™ 200 and ADAC Systems Cure Spot™ light cables, for example. A liquid filled light cable comprises a light conducting liquid core within plastic tubing. The liquid is non-toxic, non-flammable and transparent from 270 to 720 nm. The ends of a liquid filled light cable can be sealed with high quality quartz glass and metal spiral tubing surrounded by a plastic sleeve for exterior protection.
• Light transmitted tohub14 via light cable1032 is directed through illumination channels10iand delivered out oftip106ito provide an illumination at the distal tip ofstylet100. By providingstylet100 with this light emitting capability, thedistal tip106iwhen illuminated during traversing thestylet100 andirrigation catheter10 through the tortuous anatomy causes a process known as transillumination to occurs. Thus, as the irrigation system traverses through the sinus passageways, passes through an ostium and enters a sinus cavity, transillumination, which is the passing of light through the walls of a body part or organ shows a light spot on an external surface of the patient. Thus, whendistal tip106iofstylet100 is located in a sinus, the light emitted fromtip106ipasses through the facial structures and appears as a glowing region on the skin (e.g., face) of the patient. As thetip106igets closer to the surface of the structure that it is inserted into (e.g., the surface or interior wall of the sinus), the transillumination effect becomes brighter and more focused (i.e., smaller in area). Additionally, the movements of thestylet tip106ican be tracked by following the movements of the transillumination spot produced on the skin of the patient.
• Further details about the components for making a stylet as an illuminating stylet are described in co-pending, commonly assigned application Ser. No. 11/522,497 filed Sep. 15, 2006 and titled Methods and Devices for Facilitation Visualization in a Surgical Environment” which is hereby incorporated herein, in its entirety, by reference thereto.
• Illuminatingstylet100 may be provided with any of the features described above with regard to other embodiments ofstylet100 and with regard todistal tip portion106.
• FIGS. 15A-15D are illustrations of partial sagittal sectional views through a human head showing various steps of a method of gaining access to a paranasal sinus by an irrigation system as described herein to perform at least one of irrigation, suction, delivery of a therapeutic or diagnostic substance or retrieval of a culture. InFIG. 15A, a first introducing device in the form of asinus guide90 is introduced through a nostril and through anasal cavity1012 to a location close to an ostium of asphenoid sinus908. It is noted that this step is optional for placement of an irrigation system of a type described herein and may not be needed for accessing certain spaces in the anatomy, including sphenoid sinuses. Alternatively, irrigation system can be navigated without the use ofsinus guide90, by steering the tip of styletdistal end portion106 to steerdistal end portion106 and the distal end portion ofirrigation catheter10 thoughostium906 and intosinus908. For other harder to reach anatomical locations, such as the maxillary sinus, for example, asinus guide90 is typically used. For accessing a maxillary sinus, a sinus guide having a bend of 110 degrees may be needed.
• Sinus guide90 may be straight, malleable, or it may incorporate one or more preformed curves or bends as further described in U.S. Patent Publication Nos. 2006/004323; 2006/0063973; and 2006/0095066, for example, each of which are incorporated herein, in their entireties, by reference thereto. In embodiments where sinus guide90 is curved or bent, the deflection angle of the curve or bend may be in the range of up to about 135 degrees, andirrigation catheter10 does not kink as it is passed through this bent portion of the guide catheter.
• InFIG. 15B, an irrigation system comprising anirrigation catheter10 and styletdistal end portion106 are introduced through the first introduction device (i.e., sinus guide90) and advanced so that the styletdistal end portion106 exits theguide catheter90. Stylet distal end portion is then steered into thesinus ostium906 and pushed into thesinus908 with the irrigation catheter following due to the supportive characteristics of styletdistal end portion106. The irrigation system may include anirrigation catheter10 with integrated styletdistal end portion106 orirrigation catheter10 withremovable stylet100. In either case, the irrigation system can alternatively be steered and delivered from the entry at the nostril through the tortuous anatomy including the ostium and into the sinus without the use of theguide catheter90, as noted. In any case, if the surgeon decides that the predetermined length of the styletdistal end106 is not optimal, the irrigation system can be withdraw to clip a portion of the styletdistal end106, after which the irrigation system is reintroduced to continue the procedure, or the surgeon can adjust the predetermined length of the styletdistal end106 to either shorten or lengthen it, using any of the features at the proximal end of the system that were described above.
• InFIG. 15C, the distal end of irrigation catheter has entered the sinus by steering the styletdistal end portion106 and pushing on a proximal end portion of theirrigation catheter10 orirrigation catheter10 and matedstylet100. Thereafter, inFIG. 15D, the distal end ofirrigation catheter10 is inserted deep intosinus906, so thatside openings18sare positioned well within the sinus cavity to perform at least one of the functions noted above. Further, two functions, such as simultaneous irrigation and suction may be performed with at least some of the irrigation systems described herein.FIG. 15D illustrates an irrigation procedure being performed, as irrigation fluid is jetted throughopenings18sto establish vortices to clean the walls of the sinus by the irrigation flow.
• These procedures may be performed as stand-alone procedures, or they may be follow-up procedures performed after performing some other procedure such as a dilation of the ostium, as just one example. In this case, when a guidewire is used to deliver a working tool to the anatomy throughguide catheter90, for example, the working tool and guidewire are both removed prior to insertion of the irrigation system as described above. Further alternatively, the working tool can be removed while leaving the guidewire in place, and anirrigation catheter10 that is designed to function with aremovable stylet100 can instead be delivered over the guidewire without the use of theremovable stylet100. In uses where irrigation system includes anirrigation catheter10 delivered with a matedremovable stylet100, thestylet100 is removed prior to performing an irrigation, suction, substance delivery or culture retrieval function. Similarly, whereirrigation catheter10 is delivered over a guidewire, the guidewire is removed prior to performing an irrigation, suction, substance delivery or culture retrieval function. Suction may be provided with a syringe or with an operating room suction source, for example.
• It is further noted that irrigation systems described herein are not limited to only being delivered through a natural anatomic pathway, but can also be delivered though a surgical opening to irrigate, suction, deliver therapeutic and/or diagnostic substances and/or take cultures. For example, a hole may be trephined to provide direct access to the frontal sinus and an irrigation system as described herein can be delivered through the hole to flush a frontal sinus. This technique can be particularly useful for a sinus that does not communicate normally with the middle meatus. As another example, the anterior wall of the ethmoid bulla can be punctured and an irrigation system as described herein can be inserted therethrough to flush the anterior ethmoid sinuses. This procedure may be done after removal of an ethmoid sinus stent, for example. An irrigation system described herein can be delivered though a maxillary antrosotmy of Caldwell-Luc incision to perform any of the above described functions. Still further, an irrigation system as described herein may be delivered through the Eustachian tube or an incision to access the middle ear to perform any of the above-described functions in the location of the middle ear.
• FIGS. 15B-15D show anoptional scope1008 in dotted lines, that may be inserted to provide visualization of advancement ofsinus guide90 and/or inserted alongside sinus guide90 or integrated withsinus guide90, such as described in U.S. Patent Application Publication 2006/0063973, for example, which is hereby incorporated herein in its entirety, by reference thereto.Scope1008 may be a flexible scope. It is to be appreciated thatoptional scope1008 may comprise any suitable types of rigid or flexible endoscope and such optional scope may be separate from or incorporated into thesinus guide90 orirrigation catheter10. Further information about such endoscopes can be found in co-pending provisional Application Ser. No. 60/844,874, filed Sep. 15, 2006 and titled “Endoscopic Methods and Devices for Transnasal Procedures, which is hereby incorporated herein, in its entirety, by reference thereto.
• Scope1008 may provide visualization of insertion of theguide catheter90 and or at least partial visualization of advancement of the irrigation system when inserted with or withoutguide90. An illuminating stylet may be used in combination withscope1008 to provide enhanced visualization as described in more detail in application Ser. No. 11/522,497.
• Delivery of an irrigation system, with or without use of a guide catheter may be additionally or alternatively visualized by fluoroscopy, electromagnetic or optical guidance, including 3-dimensional visualization such as CT or MRI visualization or other known visualization techniques.
• In most of the embodiments described above, an irrigation catheter may be delivered into a sinus over a guidewire rather than over a stylet. (An exception includes the embodiment depicted inFIGS. 5A-5C, which has a non-removable sylet). To deliver an irrigation catheter over a guidewire, for example, a distal end of the guidewire may first be advanced into a sinus through a guide catheter, as described above and in a number of the patent applications previously incorporated by reference. In one embodiment, placement of a guidewire in a desired position in a sinus may be confirmed by fluoroscopy. Once the guidewire is in position, a flexible irrigation catheter such as many of the embodiments described above may be advanced over the guidewire to position a distal portion of the catheter in the sinus. In various embodiments, the irrigation catheter may be advanced over the guidewire through a guide catheter or, alternatively, over the guidewire without using a guide catheter. Positioning of a distal portion of the irrigation catheter in the desired sinus may be confirmed using fluoroscopy, in embodiments where the irrigation catheter distal portion includes a radiopaque marker or material. In some embodiments, the guidewire may then be withdrawn through the irrigation catheter. Irrigation fluid may then be introduced through the irrigation catheter, and in some embodiments fluid may be suctioned back through the irrigation catheter. In various embodiments, any other suitable guidewire-based delivery techniques may be employed to advance an irrigation catheter of the present invention.
• Referring now toFIGS. 16A-16E, one embodiment of aflexible irrigation catheter210 which may be advanced over a guidewire (not shown) may include acatheter body202 having alumen203, aproximal hub204, astrain relief portion206, multipleirrigation side ports208, aradiopaque marker210 and adistal irrigation port212.Side ports208 anddistal port212 are in fluid communication withlumen203. In various embodiments,catheter210 may have any suitable dimensions and may be made of any suitable materials to facilitate advancement into and irrigation of one or more paranasal sinuses. In one embodiment, for example,catheter body202 may be made of PEBAX,strain relief portion206 may be made of PEBAX covered in heat-shrink polyolefin, and radiopaque marker may be made of titanium, iridium or a combination thereof. Of course, in other embodiments one or more alternative materials may be used to make one or more of these components.
• Referring toFIG. 16A,catheter body202 may have any suitable length for treating one or more of the paranasal sinuses. In one embodiment, for example,catheter body202 may have a length of between about 10 inches and about 20 inches and more preferably between about 12 inches and about 18 inches and even more preferably between about 13 inches and about 15 inches. In one embodiment,strain relief portion206 may be located back from the distal end ofcatheter body202 between about 4 inches and about 6 inches and more preferably about 5 inches. In various embodiments, the outer diameter of catheter body may be between about 0.050 inches and about 0.100 inches and more preferably between about 0.070 inches and about 0.080 inches.
• With reference toFIG. 16B, in some embodiments,catheter body202 may include a distal taperedportion218.Tapered portion218 may measure, for example, between about 0.100 inches and about 0.200 inches in some embodiments, and more preferably between about 0.130 inches and about 0.170 inches and even more preferably between about 0.140 inches and about 0.160 inches. Aninner diameter214 ofdistal port212 may measure between about 0.020 inches and about 0.050 inches and more preferably between about 0.030 inches and about 0.040 inches. Aninner diameter216 ofcatheter body202 proximal oftapered portion218 may measure between about 0.030 inches and about 0.070 inches and more preferably between about 0.040 inches and about 0.060 inches.
• Referring now toFIG. 16C, in one embodiment,irrigation catheter210 may include threeside ports208a,208b,208c, distributed alongcatheter body202 in a helical pattern. Of course, alternative embodiments may include any suitable alternative number of side ports distributed in any suitable pattern. In one embodiment, afirst side port208amay be placed at about 5 mm±0.5 mm from the distal end ofcatheter body202, asecond side port208bmay be placed at about 6 mm±0.5 mm from the distal end ofcatheter body202, and athird side port208cmay be places at about 7 mm±0.5 mm from the distal end ofcatheter body202, with each of these measurements being from the distal end to approximately the center of eachside port208.
• Referring toFIG. 16D,side ports208 may have any suitable diameter in various alternative embodiments. For example, in one embodiment, eachside port208 may have a diameter of between about 0.020 inches and about 0.050 inches and more preferably between about 0.030 inches and about 0.040 inches and even more preferably about 0.033 inches±0.003 inches.
• With reference toFIG. 16E, which depicts the cross-section E-E fromFIG. 16C, in oneembodiment side ports208 may be distributed around the circumference ofcatheter body202 approximately 120° apart from approximately the center of eachport208 to the center of eachsubsequent port208.
• The embodiment offlexible irrigation catheter210 just described is one exemplary embodiment, and any of a number of changes may be made to the design ofirrigation catheter210 in alternative embodiments. In some embodiments,catheter210 may be suitable for advancement over a guidewire, in some embodiments it may be suitable for use with a stylet, and in some embodiments it may be suitable for use with either a guidewire or a stylet.
• While the present invention has been described with reference to the specific embodiments thereof, it should be understood by those skilled in the art that various changes may be made and equivalents may be substituted without departing from the true spirit and scope of the invention. In addition, many modifications may be made to adapt a particular situation, material, composition of matter, process, process step or steps, to the objective, spirit and scope of the present invention.

Claims (25)

1. A method for irrigating a paranasal sinus, the method comprising:

advancing a distal portion of a sinus irrigation catheter through an ostium of a paranasal sinus into the sinus; and

passing fluid through multiple ports disposed at different locations along a length of the catheter distal portion into the sinus.

2. The method ofclaim 1, wherein advancing the distal portion comprises advancing over a guidewire.

3. The method ofclaim 2, further comprising removing the guidewire through the irrigation catheter before passing the fluid.

4. The method ofclaim 3, wherein passing the fluid comprises passing fluid through three side ports distributed in a helical pattern along a length of the irrigation catheter and one distal port on the irrigation catheter.

5. The method ofclaim 1, wherein advancing the distal portion comprises advancing over a stylet.

6. The method ofclaim 1, wherein passing the fluid comprises passing fluid through multiple side ports and one distal end port on the irrigation catheter.

7. The method ofclaim 6, wherein passing the fluid comprises forming a vortex of fluid in the sinus.

8. The method ofclaim 6, wherein passing the fluid comprises passing fluid through three side ports distributed in a helical pattern along a length of the irrigation catheter and one distal port on the irrigation catheter.

9. The method ofclaim 1, further comprising:

bending the distal portion before advancing it into the sinus; and

turning the irrigation catheter while advancing it to steer the bent distal portion toward the sinus ostium.

10. The method ofclaim 1, further comprising suctioning at least some of the fluid back into the irrigation catheter through at least one of the ports.

11. The method ofclaim 1, further comprising suctioning at least some of the fluid out of the sinus using a separate suction device.

12. The method ofclaim 1, further comprising viewing a radiopaque marker of the irrigation catheter within the sinus using fluoroscopy.

13. A method for irrigating a paranasal sinus, the method comprising:

advancing a distal portion of a sinus irrigation catheter through an ostium of a paranasal sinus into the sinus; and

passing fluid through a distal end port disposed on the distal end of the irrigation catheter and three side ports disposed in a helical pattern distributed in a helical pattern along a length of the irrigation catheter into the sinus to form a vortex of irrigation fluid in the sinus.

14. A flexible irrigation catheter device for irrigating a paranasal sinus, the device comprising:

an elongate catheter body having a proximal end, a distal end, a lumen therebetween, and a tapered distal portion extending proximally from the distal end of the catheter body, wherein at least a portion of the catheter body is sized to pass through a nasal cavity and through a sinus ostium to enter a paranasal sinus;

a proximal hub coupled with the proximal end of the catheter body for connecting to a source of irrigation fluid;

multiple side ports disposed along the catheter body closer to the distal end than the proximal end and in fluid communication with the lumen; and

a distal end port at the distal end of the catheter body.

15. The device ofclaim 14, wherein the tapered distal portion of the catheter body measures between 0.140 inches and 0.160 inches.

16. The device ofclaim 15, wherein the side ports are located proximal to the tapered distal portion.

17. The device ofclaim 14, wherein the side ports comprise three side ports disposed in a helical pattern along the catheter body.

18. The device ofclaim 17, wherein the three side ports are located 5 mm±0.5 mm, 6 mm±0.5 mm and 7 mm±0.5 mm from the distal end of the catheter body.

19. The device ofclaim 18, wherein each of the side ports has a diameter of 0.033 inches±0.003 inches.

20. The device ofclaim 19, wherein each of the three side ports is disposed approximately 120° around a circumference of the catheter body relative to the other two side ports.

21. The device ofclaim 14, further comprising a radiopaque marker coupled with the catheter body at or near the tapered distal portion.

22. The device ofclaim 14, wherein a distal portion of the irrigation catheter is malleable.

23. A flexible irrigation catheter device for irrigating a paranasal sinus, the device comprising:

an elongate catheter body having a proximal end, a distal end, a lumen therebetween, and a tapered distal portion extending between 0.140 inches and 0.160 inches proximally from the distal end of the catheter body, wherein at least a portion of the catheter body is sized to pass through a nasal cavity and through a sinus ostium to enter a paranasal sinus;

a proximal hub coupled with the proximal end of the catheter body for connecting to a source of irrigation fluid;

three side ports disposed in a helical pattern along the catheter body proximal to the tapered distal portion and in fluid communication with the lumen, wherein the three side ports are located 5 mm±0.5 mm, 6 mm±0.5 mm and 7 mm±0.5 mm from the distal end of the catheter body, wherein each of the side ports has a diameter of 0.033 inches±0.003 inches, and wherein each of the three side ports is disposed approximately 120° around a circumference of the catheter body relative to the other two side ports;

a distal end port at the distal end of the catheter body; and

a radiopaque marker coupled with the tapered distal portion of the catheter body.

24. A system for irrigating a paranasal sinus, the system comprising:

an irrigation catheter comprising:

an elongate catheter body having a proximal end, a distal end, a lumen therebetween, and a tapered distal portion extending proximally from the distal end of the catheter body, wherein at least a portion of the catheter body is sized to pass through a nasal cavity and through a sinus ostium to enter a paranasal sinus;

a proximal hub coupled with the proximal end of the catheter body for connecting to a source of irrigation fluid;

multiple side ports disposed along the catheter body closer to the distal end than the proximal end and in fluid communication with the lumen; and

a distal end port; and

a guidwire over which the irrigation catheter is passable into the sinus.

25. A system as inclaim 24, wherein the side ports comprise three side ports disposed in a helical pattern along the catheter body proximal to the tapered distal portion and in fluid communication with the lumen, wherein the three side ports are located 5 mm±0.5 mm, 6 mm±0.5 mm and 7 mm±0.5 mm from the distal end of the catheter body, wherein each of the side ports has a diameter of 0.033 inches±0.003 inches, and wherein each of the three side ports is disposed approximately 120° around a circumference of the catheter body relative to the other two side ports.

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